The addendum widens the 2012 conditions. Nano zinc oxide of purity at least 96 % is covered, provided the impurities responsible for the lower purity are only carbon dioxide and water and any other impurities total less than 1 %. The median particle diameter must be above 30 nm (D1 above 20 nm). A 90-day inhalation study gave a NOAEL of 0.3 mg/m3, and SCCS does not recommend applications that lead to inhalation.
Key numbers
- Conclusion (PDF p. 13): purity ≥ 96 %, wurtzite, rod-like, star-like or isometric clusters, impurities only CO2 and water, other impurities < 1 % in total; D50 > 30 nm and D1 > 20 nm; listed silane or dimethicone coatings or uncoated; water solubility below 50 mg/L.
- Inhalation (PDF p. 13): 90-day NOAEL 0.3 mg/m3.
- These conditions appear in Annex VI entry 30a of Regulation (EC) No 1223/2009.
Methods (brief)
Committee review of additional applicant data on a 96 %-purity material and of the inhalation study. Secretariat contact: SANCO-C2-SCCS@ec.europa.eu.
Evidence fitness
Supports the purity and impurity framework in EU law for nano zinc oxide. The “other impurities below 1 %” condition is a total, not a lead or cadmium limit: 1 % equals 10,000 mg/kg, far above any element-specific impurity value in this collection.
Limitations
No analytical impurity profile by element. Applies to the nano form only.
Related evidence
- Opinion on Zinc oxide (nano form), COLIPA S 76
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast)
- Baby Sunscreen, Mineral (ZnO + TiO2)
Update history
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